WALLACH FETAL2EMR 902300 User manual

37474 • Rev B • 2/12
Fetal Monitor
REF 902300

- I -
Statement
The manufacturer makes no warranty of any kind with regard to this material, including, but not limited to
the implied warranties of merchantability and fitness for a particular purpose.
Wallach Surgical Devices (hereinafter called Wallach) assumes no responsibility for any error that may
appear in this document, or for incidental or consequential damage in connection with the furnishing,
performance or use of this material.
No part of this document may be photocopied, reproduced or translated to another language without prior
written consent of Wallach.
All information contained in this publication is believed to be correct. Wallach shall not be liable for
errors contained herein nor for incidental or consequential damages in connection with the furnishing,
performance, or use of this material.
The information contained in this document is subject to change without notice.
Responsibility
Wallach is responsible for any effect on safety, reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorized by Wallach.
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
NOTE: This device is not intended for home use, Intensive Care Unit’s or Operating
Rooms.
WARNING : This device is not intended for treatment.
Using This Label Guide
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal injury or
death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate
data, or invalidate a procedure.
NOTE: A NOTE provides useful information regarding a function or a procedure.

- II -
Table of Contents
Chapter 1 Safety Guide ................................................................................................................. 1
1.1 Intended Use........................................................................................................................1
1.2 Instruction for Safe Operation.............................................................................................1
1.3 Ultrasound Safety Guide .....................................................................................................2
1.4 Safety Precautions...............................................................................................................2
1.5 Definitions and Symbols .....................................................................................................6
Chapter 2 Monitor and Accessories.............................................................................................. 8
2.1 Opening and Checking Package..........................................................................................8
2.2 Overview .............................................................................................................................9
2.2.1 Keys and Control Knob...........................................................................................11
2.2.2 Indicators.................................................................................................................13
2.3 Accessories........................................................................................................................14
2.3.1 Ultrasound (US) Transducer ...................................................................................14
2.3.2 TOCO Transducer...................................................................................................14
2.3.3 Belt ..........................................................................................................................14
2.3.4 Remote Event Marker .............................................................................................15
2.4 Screen................................................................................................................................15
2.4.1 Main Interface .........................................................................................................15
2.4.2 Setup Interface ........................................................................................................17
Chapter 3 Installation Guide....................................................................................................... 18
3.1 Installing Battery...............................................................................................................18
3.2 Installing Monitor .............................................................................................................20
3.3 Loading Recorder paper....................................................................................................20
3.4 Tearing Off Recorder paper ..............................................................................................23
3.5 Adjusting Screen Angle ....................................................................................................23
3.6 Connecting Transducers....................................................................................................24
3.7 Placing Accessories in the Holder.....................................................................................24
3.8 Connecting Power Cable...................................................................................................25
Chapter 4 Alarms ......................................................................................................................... 26
4.1 Alarms Classification ........................................................................................................26
4.2 Audible Alarm...................................................................................................................26
4.3 Visual Alarm .....................................................................................................................26
4.4 Choosing Alarm Silence Duration ....................................................................................27
4.5 Choosing Alarm Display Form .........................................................................................27
4.6 Changing Alarm Volume ..................................................................................................28
4.7 Reviewing Alarms.............................................................................................................28
4.8 Alarm Treatment Measures...............................................................................................28
4.9 Testing Alarms ..................................................................................................................28
4.10 Patient Alarm Defaults....................................................................................................29
Chapter 5 Printing ....................................................................................................................... 30
5.1 Function Description.........................................................................................................30
5.2 Printing Configuration ......................................................................................................30
5.2.1 Switching Auto Start Printing On or Off ................................................................31

- III -
5.2.2 Choosing Paper Speed ............................................................................................31
5.2.3 Changing Print Timer..............................................................................................31
5.2.4 Switching Print Self-Check On or Off....................................................................32
5.3 Understanding Recorder Paper Printout............................................................................32
Chapter 6 Pre-Monitoring Preparation ..................................................................................... 34
6.1 Confirming Fetal Life .......................................................................................................34
6.2 Switching On.....................................................................................................................34
6.3 Checking Recorder Paper..................................................................................................35
6.4 Setting Date and Time.......................................................................................................35
6.5 Adjusting Volume .............................................................................................................36
Chapter 7 Fetal Monitoring ........................................................................................................ 37
7.1 Monitoring Fetal Heart Rate (FHR) with Ultrasound.......................................................37
7.1.1 Parts Required .........................................................................................................37
7.1.2 FHR Monitoring Procedure.....................................................................................37
7.1.3 Switching the FHR Alarm On or Off......................................................................39
7.1.4 Changing FHR Alarm Limits..................................................................................39
7.1.5 Changing FHR Alarm Delay...................................................................................39
7.2 Monitoring Twin FHRs.....................................................................................................40
7.2.1 Monitoring Twins Externally..................................................................................40
7.2.2 Signals Overlap Verification (SOV) .......................................................................40
7.2.3 Changing FHR2/DFHR Offset................................................................................40
7.3 Monitoring Uterine Activity Externally............................................................................41
7.3.1 Parts Required .........................................................................................................41
7.3.2 TOCO Monitoring Procedure .................................................................................41
7.3.3 Changing UA Baseline............................................................................................41
7.4 Monitoring Fetal Movement .............................................................................................42
7.4.1 Auto Fetal Movement Monitoring (AFM)..............................................................42
7.4.2 Enabling or Disabling AFM Trace..........................................................................42
7.4.3 Changing AFM Gain...............................................................................................42
7.4.4 Manual Fetal Movement Monitoring (MFM) .........................................................43
7.4.5 Changing MFM Volume .........................................................................................43
7.5 Starting Monitoring...........................................................................................................43
7.6 Inputting Maternal Information (Mat. Info)......................................................................43
7.6.1 Auto ID....................................................................................................................43
7.6.2 Changing Maternal Information..............................................................................44
7.6.3 Switching Mat. Info Inputting On or Off ................................................................44
Chapter 8 Understanding Measurement Results ...................................................................... 45
8.1 Changing Screen Display Mode........................................................................................45
8.2 Traces ................................................................................................................................47
8.2.1 Changing Time Scale ..............................................................................................48
8.2.2 Searching for a Patient’s Record.............................................................................48
8.2.3 File Management (Optional) ...................................................................................49
8 . 2 . 4 R e v i e w i n g ……………………………………………………………………………………5 2
8.3 Number Values..................................................................................................................51
8.4 Alarm Messages................................................................................................................52
Chapter 9 After Monitoring ........................................................................................................ 54
9.1 Saving Data .......................................................................................................................54

- IV -
9.2 Completing the Monitoring...............................................................................................54
9.3 Switching Off ....................................................................................................................54
Chapter 10 Maintenance and Cleaning...................................................................................... 55
10.1 Maintenance ....................................................................................................................55
10.1.1 Maintaining Inspection..........................................................................................55
10.1.2 Maintenance of Monitor........................................................................................55
10.1.3 Maintenance of Transducers .................................................................................56
10.1.4 Storage of Recorder Paper ....................................................................................56
10.1.5 Maintenance of Recorder ......................................................................................56
10.2 Cleaning ..........................................................................................................................57
10.2.1 Cleaning of the Monitor ........................................................................................57
10.2.2 Cleaning of Accessories........................................................................................58
10.3 Disinfecting.....................................................................................................................59
10.4 Sterilizing ........................................................................................................................59
Chapter 11 Warranty and Service Policy................................................................................... 60
Appendix 1 Product Specifications............................................................................................. 61
A1.1 Environmental Specifications ........................................................................................61
A1.2 Physical Specifications...................................................................................................61
A1.3 Performance Specifications............................................................................................62
A1.4 Recorder Specifications..................................................................................................63
A1.5 Rechargeable Lithium-ion Battery Specifications .........................................................64
A1.6 Low Output Summary Table..........................................................................................65
Appendix 2 Signal Input/Output Connector ............................................................................. 66
Appendix 3 Troubleshooting ....................................................................................................... 67
A3.1 No Display......................................................................................................................67
A3.2 Noise...............................................................................................................................67
A3.3 Recorder Error................................................................................................................67
A3.4 Trouble with Ultrasound FHR Monitoring ....................................................................68
A3.5 Troubles with Contractions Monitoring (External)........................................................68
A3.6 Blown Fuses ...................................................................................................................69
A3.7 Paper Jam .......................................................................................................................70
Appendix 4 Abbreviation............................................................................................................. 72
Appendix 5 Ordering Information ............................................................................................. 73
Appendix 6 EMC Information – Guidance and Manufacturer’s Declaration ....................... 74
A6.1 Electromagnetic Emissions – for all EQUIPMENT and SYSTEMS.............................74
A6.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS .............................75
A6.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEM that are not
LIFE-SUPPORTING ..............................................................................................................77
A6.4 Recommended Separation Distance...............................................................................79
Appendix 7 Limitations of Ultrasonic Monitoring.................................................................... 80
A7.1 How Does Ultrasound Work..........................................................................................80
A7.2 Artifacts in Fetal Heart Monitoring................................................................................80
A7.3 Audio Output and Screen Reading.................................................................................82

Chapter1:SafetyGuide
- 1 -
Chapter 1 Safety Guide
NOTE:
For Operator and Patient safety, please read through this instruction manual before using the
Wallach Fetal2EMR Fetal Monitor.
1.1 Intended Use
The Wallach Fetal2EMR (Model F3) Fetal Monitor (hereinafter called Fetal2EMR) is intended
for non-invasive monitoring of a single or twin fetuses during antepartum examination, labor and
delivery. It is intended to be used only by trained and qualified personnel in antepartum
examination rooms, labor and delivery rooms.
The Fetal2EMR provides fetal monitoring. It can externally monitor the Fetal Heart Rates (FHRs)
using ultrasound and uterine activity via a TOCO transducer.
Contraindications: The Fetal2EMR Monitor is not intended for use in intensive care units,
operating rooms or for home use.
1.2 Instruction for Safe Operation
The Fetal2EMR Monitor is designed to comply with the international safety requirements
IEC/EN 60601-1 for medical electrical equipment. It is class I equipment.
The Fetal2EMR Monitor operates within specifications at ambient temperatures between
+5ºC (+41ºF) and +40ºC (+104ºF). Ambient temperatures that exceed these limits could
affect the accuracy of the instrument and cause damage to the modules and circuits. Allow at
least 5 cm (2 inches) clearance around the instrument for proper air circulation.
You must check that the equipment, cables and transducers do not have visible evidence of
damage that may affect patient safety or monitoring capability before use. If damage is
evident, replacement is recommended.
The Fetal2EMR Monitor must be serviced only by authorized and qualified personnel.
Wallach Surgical Devices does not accept responsibility for safety compliance, reliability
and performance if modifications or repairs are carried out by unauthorized personnel.
Identical replacement parts must be used.
Perform periodic safety testing to ensure proper patient safety. This should include leakage
current measurement and insulation testing. The recommended testing interval is once per
year.
The protective categories against electric shock of the patient connections are:

Chapter1:SafetyGuide
- 2 -
1) Ultrasound (FHR1, FHR2) 2) External TOCO
3) Intrauterine Pressure (IUP) 4) Fetal Movement Mark (FM)
This symbol indicates that the electric shock defend grade of this applied part is Type BF.
DECG (Direct Electrocardiography) (Not available in this model)
This symbol indicates that the protection against electric shock of this applied part is Type CF.
The monitor described in this User Manual is not protected against:
a) The effects of defibrillator shocks
b) The effects of defibrillator discharge
c) The effects of high frequency currents
d) The interference of electrosurgery equipment
1.3 Ultrasound Safety Guide
Fetal Use
The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor.
Clinical interpretation of fetal heart rate traces may be helpful in the diagnoses of fetal and/or
maternal problems and complications.
Instructions for Use in Minimizing Patient Exposure
The acoustic output of the Fetal2EMR Monitor is internally controlled and cannot be varied by
the operator in the course of the examination. The duration of exposure is, however, fully under
the control of the operator. Mastery of the examination techniques described in the User Manual
will facilitate obtaining the maximum amount of diagnostic information with the minimum
amount of exposure. Exercising clinical judgment in monitoring low risk patients will avoid
unnecessary insonation.
1.4 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.

Chapter1:SafetyGuide
- 3 -
WARNING
Usage Safety Precautions:
1The monitor is provided for the use of qualified physicians or personnel professionally
trained. They should be familiar with the contents of this user manual before operation.
2Only qualified service technicians can install this equipment. Only service technicians
authorized by Wallach Surgical Devices can open the case.
3This device is not intended for use in intensive care units, operating rooms or for home use.
4EXPLOSION HAZARD - Do not use this device in the presence of flammable anesthetic
mixture with air, with oxygen or with nitrous oxide.
5SHOCK HAZARD –The power receptacle must be a three-wire grounded outlet. A hospital
grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot
outlet.
6Do not apply this monitor and other ultrasonic equipment simultaneously on a same patient,
due to the potential of leakage current superposition.
7Do not apply this monitor simultaneously with other PATIENT-connected equipment, such as,
a cardiac pacemaker or other electrical stimulators.
8Do not use the monitor with RF surgical equipment.
9Do not switch on device power until all cables have been properly connected and verified.
10 Do not touch the signal input or output connector and the patient simultaneously.
11 Equipment and devices that connect to the Monitor should form an equipotential body to
ensure effective grounding.
12 Disconnect power cord before changing fuses. Replace the fuses with those of the same
specifications only.
13 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands.
Make certain that your hands are clean and dry before touching a power cord.
14 SHOCK HAZARD - Do not remove the top panel cover during operation or while power is
connected. Only authorized service personnel could remove the unit cover.
15 The monitor is not protected against defibrillation. Do not apply it during electrosurgery or
MRI; as it might result in harm to the patient or the operator.
16 Only connect accessories supplied or recommended by Wallach Surgical Devices to the
device.
17 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). All configurations shall comply
with the valid version of the system standard IEC/EN 60601-1-1. Anyone who connects
additional equipment to the signal input connector or signal output connector configures a
medical system and therefore is responsible that the system complies with the requirements
of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our

Chapter1:SafetyGuide
- 4 -
technical service department or your local distributor.
Proper Monitoring Safety Precautions:
1Clinical decision making based on the output of the device is left to the discretion of the
provider.
2Alarms may be set up based on different situations. Audio should be activated when monitor
is in use.
Battery Safety Precautions:
1Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read
the user manual and safety precautions thoroughly.
2Do not connect the battery cable connector or battery socket with metal objects, which can
result in short circuit.
3Do not unplug the battery when monitoring.
4Do not heat or throw the battery into a fire.
5Do not use or leave battery close to fire or other places where the temperature may be above
+60 ºC (+140 ºF).
6Do not allow the battery to get wet.
7Do not destroy the battery: Do not pierce battery with a sharp object such as a needle; do not
hit with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or
modify the battery.
8Use the battery only in this Monitor. Do not connect battery directly to an electrical outlet or
cigarette lighter charger.
9If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well with
clean water and see a doctor immediately.
10 Do not solder the leading wire and the battery terminal directly.
11 If the liquid leaks from the battery and spills onto your skin or clothes, wash well with fresh
water immediately.
12 Keep battery away from flames. If leakage or foul odor is detected discontinue use.
13 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
14 Do not use a battery that is visually damaged.
15 Proper disposal is required. Follow your Local Regulations for disposal.
CAUTION
1U.S. Federal law restricts this device to sale by or on the order of a physician.
2Only qualified personnel shall service the unit.
3The device is designed for continuous operation.